Genzyme links up with Hospira for manufacturing help

Following a series of high-profile problems at one of its facilities, Genzyme Corp has signed a deal with Hospira which will see the latter perform contract manufacturing services for a number of the US biotechnology group’s drugs.

In a US Securities Exchange Commission filing, Genzyme revealed that Hospira will perform ‘fill and finish’ manufacturing services for Cerezyme (imiglucerase) for Gaucher disease, Fabrazyme (agalsidase beta) for Fabry disease, Myozyme (alglucosidase alpha) for Pompe disease and Thyrogen (thyrotropin alpha) for thyroid cancer. The deal comes after Genzyme’s Allston Landing, Boston facility was temporarily shut down in June after a bioreactor was contaminated with a virus, particularly affecting production of Cerezyme and Fabrazyme.

In November, the US Food and Drug Administration warned of the potential for foreign particle contamination in all lots of the four aforementioned therapies plus Aldurazyme (laronidase) for mucopolysaccharidosis type I. The agency noted that the particles, containing stainless steel fragments, non-latex rubber from the vial stopper, and “fibre-like material from the manufacturing process” could potentially cause serious adverse events.

The Hospira agreement expires on December 31, 2015 and will be automatically extended for additional terms of two years, if necessary. The pact is also dependent on Hospira's manufacturing facility receiving regulatory approvals.